Things have progressed nicely for Ruby Casareno, Vice President, Chemistry, Manufacturing and Controls (CMC), Allakos Inc. For executives wishing the same for your CMC leadership and organization, there are lessons on why that’s the case. Those lessons also recall for Casareno an earlier experience where progression traversed a rockier road. It all adds up to 6 best practices particular to outsourcing drug development and manufacturing.
Managing clinical supplies is hard. Not hard like string theory — more like organizing a family vacation with your adult siblings and all their children. Clinical supplies management sits at the intersection of multiple disciplines, each with its unique perspectives and priorities. Their collective attention may be difficult to hold for something as seemingly trivial as packaging. However, clinical packaging is critical to the success of a program and a company, and an effective request for proposal (RFP) will guide you to the right packaging partner for your journey to product approval.
Whether to rotate disinfectants has been debated in the pharmaceutical industry for years. If disinfectants are not used properly, microorganisms may remain on surfaces and proliferate in the environment. This article discusses the concept of disinfectant rotation and the current mainstream industry practice regarding it.
Gone are the days when we could count the number of immunology drugs on the market with our two hands. Today, the market is crowded with not only an abundance of originator biologics, but also an increasing supply of biosimilar products
The aim of this white paper is to demonstrate how GE Healthcare Life Sciences single-use products can be applied in the field of vaccine manufacturing. The white paper includes a brief discussion around modern vaccine processes, followed by a case study showing the scale-up of upstream and downstream processes for the production of a cell based live attenuated influenza virus using single-use ReadyToProcess technology.
Capsular polysaccharides (CPS) of encapsulated bacterial pathogens can give rise to an effective immune response in humans, and are commonly used in vaccine production. This whitepaper offers an overview of modern tools and technologies that can facilitate CPS-based vaccine production. An alternative purification approach based on chromatography, replacing many of the ethanol and phenol extraction steps of the traditional process, is also presented. Using the proposed purification platform, 28 different CPS of three different species could be processed to high purity and yield in a secure and environmentally friendly way.
By dispelling the myths associated with biocatalysis, a manufacturer can reap the benefits of this technology, providing a route to greener, safer chemistry that delivers a higher overall yield.
Here we describe a process development methodology that enables design of either a batch or a continuous chromatography step based on the same set of experimental data.
Dedicated Fermentation Technology Replacing Stainless Steel Systems in Bioprocess Markets
This white paper outlines how connectivity and comprehensive automation solution can facilitate technology transfer and scaling from process development to final manufacturing scale.
How Electronic Trial Master Files (eTMFs) Work With Other eClinical Systems To Help You Meet Regulatory Requirements.
Seamless teamwork among INC Research/inVentiv Health, sponsor and sites results in multinational studies with zero audit findings.
Microcarriers are commonly used in bioreactor cultures to provide a large growth surface for anchorage-dependent cells, and are typically provided either untreated or gamma-irradiated and ready for use. The process economy comparison performed in this work was made for the preparation step of Cytodex 1 versus Cytodex 1 Gamma microcarriers. Two scales were included: 100 L pilot and 500 L production scales.
Advances in single-use bioprocess technology have led to the development of the Thermo Scientific HyPerforma Single-Use Fermentor (SUF), the first specifically designed fermentor of its kind.
Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.
About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.
About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.
An outline of the cell development and process scale-up for an antibody program in which the antibody requires additional processing by a site-specific enzyme for correct functionality.
Many biologics companies will partner with a contract development and manufacturing organization that can provide the required expertise and resources as well as flexibility of operations.
As drug developers face the ever-pressing need to get molecules to market as efficiently as possible, firms large and small are increasingly turning to CDMOs for help.
Trevor Marshall of Zenith Technologies discusses the impact that multi-product manufacturing facilities, single-use technologies, continuous manufacturing and industry 4.0 will have on automation.
How to understand and prepare for challenges early in development to avoid bottlenecks that significantly slow production and delay a drug’s time-to-market.
